Device and method for treating varicose veins

ABSTRACT

A surgical instrument for treatment of superficial varicose veins in a body is provided. The surgical instrument includes at least one vein-engaging element disposed within or on a housing being adapted for insertion into a tissue. The at least one vein-engaging element is operable to a vein-engaging state whereby it protrudes from the housing at a length thereof.

RELATED APPLICATIONS

This Application is a National Phase of PCT Patent Application No.PCT/IL2005/000494 having International Filing Date of May 10, 2005,which claims the benefit of Israel Patent Application No. 161928 filedon May 11, 2004, now Israel Patent No. 161928 issued on Feb. 21, 2006.The contents of the above Applications are all incorporated herein byreference.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to devices for treating varicose veins ingeneral, and in particular, to a surgical instrument for removingvaricose veins.

Varicose veins are a condition of the superficial veins of the lowerextremities in which one or more one-way valves within the veins haveceased to function efficiently, resulting in blood flow contrary to thenormal direction of flow. This results in the build up of pressureinside portions of the vein, causing the veins to become abnormallytwisted, distorted and prominent, yielding unsightly and often painfulbulges on the lower extremities. Some 20% of women in the generalpopulation suffer from some degree of varicose veins. In some 5-7% ofsufferers, an operation is required in order to remove the damagedveins, so as to permit blood flow through alternative routes. In others,cosmetic surgery and treatment are desired in order to remove theunsightly superficial varicose veins from the extremities.

The surgical instruments for removal of superficial varicose veins fromlower extremities that can be found on the market today are relativelyexpensive, technically complex, complicated in use and require anincision through a skin layer over each superficial varicose vein orvein-knot (using the Winkling method) which is to be removed. The resultcan be ten to fifteen incisions during a single operation. Theseincisions result in the formation of many unattractive scars and,sometimes, in inflammation and infection.

One example of a conventional method and apparatus for removing varicoseveins is described and claimed in U.S. Pat. No. 6,436,116 to Spitz etal. The method described in this patent includes making an incisionthrough a skin layer of a patient, inserting a surgical instrumentincluding a light source through the incision, visualizing the veinthrough the skin layer using the light source positioned subcutaneouslyand in proximity of the vein, and cutting the vein using the surgicalinstrument. The instrument further includes means for irrigating andtumescing a surgical region in proximity of the vein, and a vacuumsource for aspirating cut venous tissue through the surgical instrument.This apparatus is very complicated, is complex to manufacture andmaintain, and requires electricity to function.

A simpler apparatus is shown in U.S. Pat. No. 5,792,168. This apparatusis used to form an incision through the skin layer and engage asuperficial vein for extraction of a segment of the vein through theincision. Once extracted, the exposed ends of the superficial vein maybe ligated using known surgical techniques, and the ligated portions ofthe vein will return back through the incision. The apparatus of thispatent includes a cylindrical shaft having a needle or scalpel at oneend thereof for making an incision through the skin layer, and acylindrical sleeve about the shaft arranged to slide relative to theneedle. The facing surfaces of the needle and the cylindrical sleevedefine a gripping region therebetween, and the gripping region canselectively engage the varicose vein to permit lifting of a selectedportion of the vein out through the incision. This instrument alsorequires a separate incision above each vein to be treated.

Accordingly, there is a need for a surgical device for removingsuperficial varicose veins while requiring a relatively small number ofincisions for effective treatment, and as a result improving cosmeticeffects and reducing patient discomfort.

SUMMARY OF THE INVENTION

According to one aspect of the present invention there is provided asurgical instrument for treatment of superficial varicose veins in abody comprising at least one vein-engaging element disposed within or ona housing being adapted for insertion into a tissue (e.g. subcutaneoustissue), the at least one vein-engaging element being operable to avein-engaging state whereby the at least one vein-engaging elementprotrudes from the housing at a length thereof.

According to further features in preferred embodiments of the inventiondescribed below, the housing is a hollow tube.

According to still further features in the described preferredembodiments the surgical instrument further comprises a substantiallytapered tip located at an end of the housing, the tip being designed forallowing introduction of the surgical instrument into an incisionthrough a skin layer.

According to still further features in the described preferredembodiments the surgical instrument further comprises a substantiallypointed tip located at an end of the housing, the tip being designed forallowing introduction of the surgical instrument into an incisionthrough a skin layer.

According to still further features in the described preferredembodiments the at least one vein-engaging element is a toothedvein-engaging element.

According to still further features in the described preferredembodiments the housing comprises at least one longitudinal slit forenabling the at least one vein engaging element disposed within thehousing to protrude from the housing when in the vein engaging state.

According to still further features in the described preferredembodiments the at least one longitudinal slit is parallel to alongitudinal axis of the housing.

According to still further features in the described preferredembodiments the surgical instrument further comprises a state selectormechanism designed to operate the at least one vein-engaging element toa vein-engaging state.

According to still further features in the described preferredembodiments the state selector mechanism includes a plunger beinginsertable into the housing.

According to still further features in the described preferredembodiments the surgical instrument further comprising a locking elementfor locking the plunger when the vein-engaging element is in thevein-engaging state.

According to still further features in the described preferredembodiments the locking element includes a cylindrical collar about theplunger adapted and configured to frictionally engage a complementarydepression in the hollow housing.

According to still further features in the described preferredembodiments the state selector mechanism includes at least one springbeing for urging the at least one vein-engaging element to avein-engaging state.

According to still further features in the described preferredembodiments the state selector mechanism includes an electricallyactivated servo mechanism for urging the at least one vein-engagingelement to a vein-engaging state.

According to still further features in the described preferredembodiments the housing includes four longitudinal slits for enablingfour toothed vein-engaging elements for selectively protruding throughthe slits, whereas the state selector mechanism is capable ofsimultaneously urging the four toothed vein-engaging elements to avein-engaging state.

According to still further features in the described preferredembodiments the surgical instrument has a length of about 12 to 16 cmand a width of about 2 to 8 mm.

According to another aspect of the present invention there is provided amethod of treating superficial varicose veins in a body region, themethod comprising: (a) forming an incision in a skin layer adjacent tothe body region; (b) inserting, through the incision a surgicalinstrument having a housing configured with at least one vein-engagingelement being operable to a vein-engaging state whereby it protrudesfrom a length of the housing; (c) activating the at least one veinengaging element to the vein-engaging state; and (d) removing thesurgical instrument, thereby treating the superficial varicose veins inthe body region.

According to still further features in the described preferredembodiments steps (a)-(d) are repeated, thus forming an at least oneadditional incision, wherein the distance between two adjacent incisionsalong the same vein is greater than about 10 cm.

According to still further features in the described preferredembodiments step (b) is effected by inserting the surgical instrumentinto a varicose vein.

According to still further features in the described preferredembodiments step (c) is operable using a state selector forming a partof the surgical instrument.

According to still further features in the described preferredembodiments the housing is a hollow tube.

According to still further features in the described preferredembodiments the method further comprises a substantially pointed tiplocated at an end of the housing, the tip being designed for allowingintroduction of the surgical instrument into an incision through a skinlayer.

According to still further features in the described preferredembodiments the at least one vein-engaging element is a toothedvein-engaging element.

According to still further features in the described preferredembodiments the housing comprises at least one longitudinal slit forenabling the at least one vein engaging element disposed within thehousing to protrude from the housing when in the vein engaging state.

The present invention successfully addresses the shortcomings of thepresently known configurations by providing a surgical instrument whichenables effective treatment of varicose veins through a small number ofincisions and thus treatment therewith minimizes patient discomfort andscarring.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In case of conflict, the patentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention. In this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice.

In the drawings:

FIGS. 1A-1M illustrate various embodiments of a surgical instrument forvaricose vein treatment according to the teachings of the presentinvention.

FIGS. 2A-2B illustrate a side view of a surgical instrument constructedand operative in accordance with one embodiment of the presentinvention, in a non vein-engaging state (FIG. 2A), and in avein-engaging state (FIG. 2B).

FIGS. 3A-3D illustrate a side sectional view (FIG. 3A) and a crosssectional view (FIG. 3B) of a surgical instrument constructed andoperative in accordance with another embodiment of the present inventionin an initial state prior to engaging a vein and at a vein-engagingstate.

FIG. 4 illustrates a perspective view of a surgical instrumentconstructed and operative in accordance with another embodiment of thepresent invention.

FIG. 5 illustrates a side sectional view of a surgical instrumentconstructed and operative in accordance to an additional embodiment ofthe present invention in an initial state prior to being in avein-engaging state.

FIG. 6 illustrates a side sectional view of a surgical instrumentconstructed and operative in accordance with yet another embodiment ofthe present invention in an initial state prior to being in avein-engaging state.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is of a surgical instrument/device and method forremoving superficial varicose veins from a body, which instrument andmethod enable removal of several varicose veins through a singleincision.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangement of the components setforth in the following description or illustrated in the drawings. Theinvention is capable of other embodiments or of being practiced orcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein is for the purpose ofdescription and should not be regarded as limiting.

Devices for removing varicose veins are well known in the art, see forexample U.S. Pat. No. 6,436,116 to Spitz et al. and U.S. Pat. No.5,792,168 to Surval. In order to be effective, such devices require anoperator to perform numerous incisions in order to treat varicose veinpresent in a body region targeted for treatment.

The present invention describes an instrument of a design whichspecifically addresses this limitation of prior art devices.

Thus, according to one aspect of the present invention there is provideda surgical instrument for treatment of superficial varicose veins in abody.

As used herein the phrase varicose veins refers to abnormally swollen ordilated veins.

As used herein the term “treating” when relating to varicose veins,refers to attenuating, or eliminating varicose veins, preferablysuperficial varicose veins of the legs.

The surgical instrument of the present invention includes at least onevein-engaging element disposed within or on a housing which is adaptedfor insertion into a tissue, such as subcutaneous tissue. As is furtherdetailed hereinunder, the vein-engaging element is operable to avein-engaging state whereby it protrudes from the housing at a lengththereof.

Reference is now made to FIGS. 1A-1M, illustrating various embodimentsof the surgical instrument of the present invention, which is referredto hereinunder as surgical instrument 10.

Surgical instrument 10 includes a housing 12 and at least onevein-engaging element 14 (three are shown in FIGS. 1A-B) which isdisposed within or on housing 12 (on one or more sides). Preferably,surgical instrument 10 also includes a state selector mechanism 20 (alsoreferred to hereinunder as mechanism 20) which is designed for urgingvein engaging element 14 from a closed state to a deployed state(further described below).

Housing 12 can be designed as an elongated member, which can be hollowor partially hollow for containing vein-engaging element(s) 14 within it(as shown in FIG. 1B). Housing 12 can be a flattened hollow housing 12b, like a knife with an extendable blade as shown in FIG. 1I, or ahollow tube 12 b as shown in FIG. 1J, or any other desired design havingan interior volume for containing at least one vein engaging-element 14when in a non-deployed (closed) state. To enable deployment of veinengaging element 14, hollow housing 12 includes at least one openingthat can be shaped as a circular hole or preferably a longitudinal slit36 which is parallel to a longitudinal axis 38 of hollow housing 12 (asshown in FIG. 1G). Alternatively, housing 12 may also be a non-hollow,in which case vein-engaging elements 14 are positioned adjacent to andpreferably flush with housing 12 (as shown in FIG. 1E). Preferably,housing 12 has a length (L) of about 12-16 cm (see FIGS. 1I-J), and adiameter/width (D), which varies from about 2 to 8 mm (depending on thedimensions of the varicose veins or vein-knots).

Housing 12 is preferably formed with a tapered tip 25 (as shown in FIG.1I), or a pointed tip 26 (as shown in FIG. 1J) at a distal end 28thereof (distal—with respect to an operator). Such a tip configurationenables non-traumatic introduction of surgical instrument 10 through anincision 30 made in skin layer 32 (as shown in FIGS. 1C-D). Tapered (25)or pointed (26) tips as well as housing 12 are preferably fabricatedfrom any appropriate bio-compatible material, including, for example,polymers or metals or any combination thereof.

Vein engaging element 14 is constructed from any suitable material(e.g., a biocompatible metal or polymer or a combination thereof), andis configured for engaging a vein 34 when in a vein-engaging state(deployed state). Vein-engaging element 14 can be a toothedvein-engaging element 16 (as shown in FIGS. 1K-L), or a hookedvein-engaging element 18 (as shown in FIG. 1M). In any case, the shapeand size of vein engaging element 14 is selected so as to enable veinengagement when surgical instrument 10 is in operation. FIG. 1Killustrates a single toothed vein-engaging element 16 having arelatively wide base 13, narrowing to a sharp pointed tooth 15 at theouter edge. Furthermore, tooth 15 may have any desired shape as long asit slopes towards proximal end 24 of surgical instrument 10 (towards anoperator). Sharp pointed tooth 15 must slope towards proximal end 24,for puncturing, engaging and removing or tearing a wall of vein 34 whilesurgical instrument 10 is being removed (pulled out) from the tissue ofthe patient. FIG. 1L illustrates a toothed vein-engaging element 16having a plurality of sharp pointed teeth 15. Using plurality of sharppointed teeth 15 in a toothed vein-engaging element 14 enables treatmentof vein 34 more efficiently, since it increases the likelihood of veinengagement. FIG. 1M illustrates a hooked vein-engaging element 18 havingthe shape of a hook 19. According to this embodiment hook 19 catchesonto vein 34 or its wall and when surgical instrument 10 is removed,hook 19 tears vein 34.

Vein engaging element 14 is operable from a closed state in which it issequestered within housing 12 or flush against it (see FIGS. 1E-F) to adeployed state (vein engaging state—a state which enable element 14 toengage a vein), in which it protrudes from housing 12 (See FIG. 1A).FIGS. 1E and 1F illustrate two embodiments of vein-engaging element 14placement. FIG. 1E illustrates surgical instrument 10 constructed suchthat vein engaging element 14 is placed on housing 12. FIG. 1Fillustrates the surgical instrument 10 constructed such that the atleast one vein engaging element 14 is placed within housing 12. In orderto enable the latter embodiment, housing 12 is a hollow housing 12 (seeFIGS. 1G-1J) having at least one longitudinal slit 36, which is parallelto a longitudinal axis 38 of the hollow housing 12. Preferably, one tofour slits 36 are included, depending on the width/diameter of housing12. Additionally, slits 36 are preferably located symmetrically abouthollow housing 12. If desired, slits 36 may be continuous for the entirelength of hollow housing 12 as shown in FIG. 1G, or constitute aplurality of shorter slits 36 spaced from one another forming brokenlines along the length of hollow housing 12 as shown in FIG. 1H, toincrease the housing's stiffness and strength.

State selecting mechanism 20 (also referred to herein as mechanism 20)is disposed within or on housing 12. Mechanism 20 is configured to beeasily operated by an operator. Any one of several state selectormechanisms 20 can be utilized by surgical instrument 10. For example,springs, levers or cams which are disposed within or on housing 12, or ahydraulic mechanism (syringe-like) which is disposed within housing 12can be utilized to activate deployment of vein engaging element 14. Suchactivation can be effected via twisting, pushing, pulling and the like.Alternatively, a simple electronic circuit which includes a powersupply, switch and servo can be utilized for such purposes. One ofordinary skill in the art would be more than capable of designing anddeploying various embodiments of state selector mechanism 20.

One embodiment of mechanism 20, illustrated in FIGS. 2A-B, is a plunger40 which is suitable for use by a hollow housing 12 embodiment ofsurgical instrument 10. Plunger 40 is sized for insertion into hollowhousing 12. FIG. 2A illustrates surgical instrument 10 with the plunger40 prior to activation of a vein-engaging state. Pushing plunger 40between vein-engaging elements 14 causes sharp pointed teeth 15 ofvein-engaging elements 14 to protrude through slits 36 (FIGS. 3C-3D),until wide base 13 is stopped by the edges of slits 36. Preferably,plunger 40 has a cone-shaped tip 42, which makes it easier to insertbetween the ends of the vein engaging elements 14, separate them, andurge them to slide towards their respective slits 36. Alternatively,vein engaging elements 14 can be coupled to one another or formed as asingle expandable unit.

Preferably, a locking mechanism 44 is provided to lock plunger 40 inplace in hollow housing 12 in the vein-engaging state of FIGS. 3C-3D. Inthe illustrated embodiment (FIGS. 3A-D), locking mechanism 44 includes acylindrical collar 46 which is adapted and configured to seat in andfrictionally engage a mating depression 48 within hollow housing 12.Alternatively, any other suitable locking mechanism can be employed topermit a surgeon to lock surgical instrument 10 in the vein-engagingstate for ease of removal of surgical instrument 10 and the vein piecesfrom the tissue of a patient.

FIGS. 3A-3D illustrate a side sectional view and a cross sectional viewof surgical instrument 10 constructed and operative in accordance withone embodiment of the present invention in an initial state prior tobeing in a vein-engaging state. In the embodiment described herein, thestate selecting mechanism 20 is the plunger illustrated in FIGS. 2A-2Bherein above. Surgical instrument 10 includes a tube shaped hollowhousing 12, and further includes four longitudinal slits 36 which areparallel to longitudinal axis 38 of hollow housing 12. Furthermore, inthis embodiment, slits 36 are located symmetrically about hollow tubehousing 12. Additionally, four toothed vein-engaging elements 16 aredisposed within hollow housing 12. Furthermore, toothed vein-engagingelements 16 are adapted and configured to selectively partially protrudethrough longitudinal slits 36. Moreover, a configuration ofvein-engaging elements 16 disposed around (e.g., following a radialpattern) the tube shaped hollow housing 12 is preferred, in order topermit the tearing and/or removal of more than one vein 34 at a time.

It will be appreciated that the thickness of the vein-engaging elementsand the length of the teeth thereon depend on the diameter of hollowhousing 12. When the instrument is assembled and ready for use, beforeinsertion of the plunger, the teeth of vein-engaging elements 16 arehidden inside housing 12. Since the teeth slope away from the tip of theinstrument, even if they protrude slightly prior to deployment, theywill be pushed back inside the tube as long as the instrument is beinginserted into the body. Once the instrument is in place, and the plungerhas been inserted to the end of the tube, the teeth preferably protrudeabout 0.5 to 1 mm from the slits. It will further be appreciated thatthe length and width of longitudinal slits 36 must be sized to ensure atight fit of wide base 13 of vein-engaging elements 14, so thatvein-engaging elements 14 cannot fall out of housing 12 through slits 36during use.

In the above described embodiment, vein-engaging elements 14 are notcoupled to one another, but rather support one another inside the tubeshaped hollow housing 12. Additionally, plunger 40 is arranged to slidebetween wide bases 13 of vein-engaging elements 14 and urge them apartfrom one another and outwards towards slits 36 of housing 12.

Reference is now made to FIG. 4 illustrating a perspective view of asurgical instrument 10 constructed and operative in accordance withanother embodiment of the present invention. In the embodiment describedherein, the state selecting mechanism 20 is the plunger 40 as describedin FIGS. 3A-3D herein above. In this embodiment, the housing 12 is aflattened housing 12 a, similar to a knife having an extendable blade.One or two vein-engaging elements 14 are disposed within housing 12 a,as is a plunger 40 for urging the at least one vein-engaging element 14outwards to the vein-engaging state.

Reference is now made to FIG. 5 illustrating a side sectional view of asurgical instrument 10 constructed and operative in accordance with anadditional embodiment of the present invention in an initial state priorto being in a vein-engaging state. In the embodiment described herein,the state selecting mechanism 20 includes a switch and a pushing element60 having a conical tip 42 as in the case of the plunger 40 described inFIGS. 2A-B. Pushing element 60 is for urging the at least onevein-engaging element 14 to protrude through the at least onelongitudinal slit 36 to a vein-engaging state (as was described for theplunger 40 in the previous embodiments herein above). Pushing element 60is advanced forward by releasing at least one spring 64 disposed withinhousing 12 by activating the switch of state selector 22. Additionally,state selector 22 can have an option of fixing pushing element 60 in thevein-engaging state after the release of spring 64.

Reference is now made to FIG. 6 illustrating a side sectional view of asurgical instrument 10 constructed and operative in accordance with yetanother embodiment of the present invention in an initial state prior tobeing in a vein-engaging state. In the embodiment described herein,state selecting mechanism 20 comprises a pushing element 60 having aconical tip 42 as in the case of the spring described in FIG. 5. Pushingelement 60 is for urging vein-engaging element 14 to protrude throughlongitudinal slit 36 to a vein-engaging state (as was described in theprevious embodiments herein above). According to this embodiment,pushing element 60 is advanced forward by activating an electricalcircuit 68 disposed within housing 12. A power source 70 (e.g., abattery) is disposed within housing 12 for enabling the activation ofthe electrical circuit 68. Furthermore, state selector 22 is used foractivating the electrical circuit, thus advancing pushing element 60 toa vein-engaging state. Additionally state selector 22 can have an optionof fixing pushing element 60 in the vein-engaging state after activatingelectrical circuit 68.

As is mentioned hereinabove, surgical instrument 10 is utilized to treatvaricose veins.

FIGS. 1C and 1D illustrate use of one embodiment of surgical instrument10. In FIG. 1C surgical instrument 10 is inserted into and through vein34 to be treated prior to being in a vein-engaging state. Surgicalinstrument 10 is then activated to a vein-engaging state and pulledback, thus tearing vein 34. It will be appreciated that although suchintra-vein insertion may be unintentional, surgical instrument 10 canstill be utilized to tear vein 34 whereas prior art devices, such asthat described in U.S. Pat. No. 5,792,168, would be incapable of suchfunctionality.

In FIG. 1D surgical instrument 10 is inserted into the body and alongvein 34 to be treated prior to being in a vein-engaging state. Surgicalinstrument 10 is then activated to a vein-engaging state and pulledback, thus tearing vein 34.

FIG. 2B illustrates use of surgical instrument 10 which includes plunger40 as mechanism 20. Pressing plunger 40 causes vein-engaging elements 16to protrude through longitudinal slit 36, for example, about 0.5 mm, andhook into or tear the wall of the adjacent varicose vein 34 or vein knot34. Preferably, plunger 40 is locked in this state, for ease ofcontinued operation. Surgical instrument 10 can be removed now from theincision 30. As surgical instrument 10 is removed, toothed vein-engagingelements 16 may be pulled against, and hook onto or pass through,additional varicose veins 34 or vein knots 34. Surgical instrument 10may be rotated about its longitudinal axis 38 while adjacent to treatedvein 34, before or while the surgical instrument 10 is removed throughthe incision 30. The damaged vein portions which are hooked onvein-engaging elements 14, will be torn, and possibly pulled free fromthe body of the patient. If surgical instrument 10 is disposable, it maynow be disposed of together with any removed vein portions. It will beappreciated that, in many cases, it is sufficient to tear the wall ofthe varicose vein 34, in order for it to cease functioning in apathogenic manner (i.e. varicose state). The bleeding usually stopswithout assistance or by applying momentary pressure on incisions 30,and big subcutaneous hematomas are highly unusual. In the few caseswhere it is required, pressure can be applied or the vein ends can betied, as is well known in the art.

This procedure is now repeated on subsequent veins 34 and vein-knots 34preferably using new surgical instrument 10 that is introduced into thesame incision 30. It will be appreciated that surgical instrument 10 canbe pivoted to any direction required in an incision 30, in order toengage the desired vein. Thus, by using one incision 30 and sequentiallyintroducing one or more instruments from different directions (anydirection around the incision), the surgeon can remove all problematicveins within a radius approximately equal to the working length, L, ofthe surgical instrument 10, for example, 12-16 cm. It will further beappreciated that the use of a single incision to remove multiplevaricose veins substantially reduces hematoma in the area followingsurgery.

If necessary, one or two additional incisions may be made in other areashaving a vein or several veins to be removed, and the above procedure isrepeated. In this fashion, by using the surgical instrument of thepresent invention, maximal clinical treatment and cosmetic effect can beachieved using only 2-3 small incisions. It will be appreciated thatthis is significantly fewer incisions than are typically required in aconventional operation. The Examples section below provides resultsobtained using the surgical instrument of the present invention. As isshown therein, the surgical instrument of the present invention ishighly efficient in treating varicose veins.

It is a particular feature of the present invention that a plurality ofveins can be removed or torn through a single incision, unlike usingconventional techniques. This has several advantages. First, thepossibility of infection is greatly reduced. Second, fewer incisionscause less trauma to the area. Third, the number of scars issignificantly reduced as compared to prior art devices and techniques,thereby providing the desired cosmetic effect and effective treatmentwith fewer complications, while leaving the extremities much moreattractive looking.

It will be appreciated that the surgical instrument of the presentinvention can also be used in cases where treatment is not immediatelyprescribed and yet cosmetic benefits can be gained.

As used herein, the term “about” denoted +1-10%.

While the invention has been described with respect to a limited numberof embodiments, it will be appreciated that many variations,modifications and other applications of the invention may be made. Itwill further be appreciated that the invention is not limited to whathas been described hereinabove merely by way of example. Rather, theinvention is limited solely by the claims which follow.

Additional objects, advantages, and novel features of the presentinvention will become apparent to one ordinarily skilled in the art uponexamination of the following examples, which are not intended to belimiting. Additionally, each of the various embodiments and aspects ofthe present invention as delineated hereinabove and as claimed in theclaims section below finds experimental support in the followingexamples.

EXAMPLES

Reference is now made to the following examples, which together with theabove descriptions; illustrate the invention in a non limiting fashion.Two clinical trials using the surgical instrument for varicose veintreatment are described herein below; the first trial relates to usageof the surgical instrument in cadavers and the second for the usage inpatients.

Example 1

Using the surgical instrument of the present invention, the presentinventors performed a trial procedure on 30 lower body limbs of 15cadavers (Table 1 below).

TABLE 1 Age of Limb Number of Incision Limb No. deceased Gender(Right/Left) Incisions Length 1 70 F R & L 3 5 mm 2 43 M R & L 3 5 mm 348 M R & L 3 5 mm 4 84 M R & L 3 5 mm 5 84 F R & L 4 5 mm 6 58 M R & L 45 mm 7 56 M R & L 4 5 mm 8 74 F R & L 2 5 mm 9 54 M R & L 4 5 mm 10 48 MR & L 4 5 mm 11 34 M R & L 4 5 mm 12 54 M R & L 4 5 mm 13 50 M R & L 4 5mm 14 Age not F R & L 4 5 mm known 15 52 F R & L 4 5 mm

As is outlined in Table 1 above, the age of the deceased ranged between34-84 years old, and the trial group included 10 males and 5 females.The surgical instrument used in this trial had a diameter of 4 mm, andthus the incisions made in the skin layer where 5 mm long. Furthermore,the incisions were made in skin regions suspected of being adjacent toveins. Extended varicose veins where observed in 5 of the cadavers.

In all cases were varicose veins were identified they veins weresuccessfully engaged and torn, and removal of the surgical instrumentindicated that no tissue other than vein and subcutaneous adipose tissuewere substantially damaged by the instrument (no remains of muscle ornerve tissue were observed on the instrument).

The results of this trial illustrated that the surgical instrument ofthe present invention can be successfully used in human tissue and thatthe vein engaging elements of the surgical instrument as well as theirplacement on the housing of the instrument enable highly effectivegrasping and tearing of varicose veins even in cases where such veinsare extended and entangled.

In addition, the above described trial also illustrated that:

(i) the surgical instrument of the present invention can be used fortreating varicose veins having a small diameter of about 1 mm;

(ii) use of the surgical instrument of the present invention enablescomplete removal of all varicose veins through 2-4 incisions only; and

(iii) in configurations having one or two vein-engaging elements and apointed tip, there is no need for performing incisions, since thepointed tip of the surgical instrument can be used for penetrating theskin; in such cases there will be no need for stitches following removalof the surgical instrument.

Example 2

The trial procedure described above was repeated on a group of patients.The purpose of this trial was to examine the use of the surgicalinstrument when applied for removal of varicose veins in a living humantissue. The operations where carried out on 5 lower body limbs of 4patients (see Table 2 below). The age of the patients operated on rangedbetween 29-60 years old, and the sampling group included one male and 3females. All females where post partum, one of which was operated onboth legs. Four operations took place under general anesthesia whileonly was performed using epidural. All patients required standardsuperficial varicose vein removal, which includes performing incisionsin the groin area and the leg. In two of the cases, two incisions wererequired while for the other three cases three incisions where required.The procedure took between 5 and 10 minutes to complete and in all casesthere were no internal bleeding observed and no hematomas were formed.External bleeding was stopped using applied pressure for 1-3 minutes. Infive surgical procedures a total of 13 incisions where made, of whichonly 9 required stitching. Following surgery, all patients wereimmediately bandaged with standard elastic bandages and re-bandged thefollowing day. During the first twelve weeks following surgery,pain-relief medication was prescribed (non-narcotic analgesic) and noneof the patients complained of strong pain which could be indicative ofunder-skin hematomas or nerve damage. This was probably due to the smallnumber of incisions and therefore reduced damage to the tissue. During a7-10 day recovery period no complications were observed and all of thepatients returned to normal life including work.

TABLE 2 Limb Number (Right/ of No. Age Gender Left) Incisions AnesthesiaComplications 1 60 M R 2 general None  2* 29 F R 3 general None L 2general None 3 48 F L 3 general None 4 54 F R 3 epidural None *operatedon both legs

The clinical trial described above conclusively shows that the surgicalinstrument is highly effective for varicose vein treatment procedures inthat it has shown to have positive affects both from the cosmetic pointof view and from the clinical point of view.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

1. A method of treating at least one superficial varicose vein in a bodyregion, the method comprising: (a) forming an incision in a skin layeradjacent to the body region; (b) inserting, through said incision andadjacent to the outside of the at least one varicose vein, a surgicalinstrument having a housing configured with a plurality of vein-engagingelements configured to engage one or more veins from a location adjacentto an outside surface of the veins, whereby the vein-engaging elementsprotrude at a length of said housing; (c) engaging, from the adjacentlocation, the outside of at least one of the at least one vein with saidsurgical instrument; (d) rotating said surgical instrument about itslongitudinal axis; and (e) removing said surgical instrument, therebytreating the at least one superficial varicose vein in the body region.2. The method according to claim 1, wherein said surgical instrument isoperable to a vein engaging state, said method further comprising, aftersaid inserting, activating said at least one vein-engaging element tosaid vein engaging state.
 3. The method according to claim 2, whereinsaid housing includes at least one longitudinal slit configured to allowsaid at least one vein-engaging element to assume said vein-engagingstate.
 4. The method of claim 2, wherein said forming, said inserting,said activating, said engaging, and said removing are repeated, thusforming at least one additional incision, wherein the distance betweentwo adjacent incisions along the same vein is greater than about twice alength of said surgical instrument.
 5. The method according to claim 1,wherein said forming includes: forming said incision in said skin layerusing a substantially sharp tip on said instrument.
 6. The methodaccording to claim 1, wherein said engaging includes manipulating saidsurgical instrument to provide at least one of: puncturing; engagingwith said at least one vein engaging element; and tearing.
 7. The methodaccording to claim 6, wherein said manipulating further comprises atleast one of: (1) pivoting said housing on a plane parallel to a surfaceof said skin layer; (2) ensnaring at least a portion of said at leastone first vein; (3) rotating said housing along a longitudinal axis ofsaid housing; (4) wrapping at least a portion of said at least one firstvein around said housing; (5) pulling at least a portion of said atleast one first vein; and (6) severing a first portion of said at leastone vein from a second portion of said vein and leaving said vein insaid body region.
 8. The method according to claim 7, wherein saidsurgical instrument is operable to a vein-engaging state, said methodfurther comprising, after said inserting, activating said at least onevein-engaging element to said vein engaging state; wherein said incisioncomprises at least one first incision and following said removing: (f)forming a second incision in a skin layer adjacent to the body region,said second incision located a distance of about twice a length of saidsurgical instrument from said at least one first incision; (g) insertingsaid surgical instrument through said second incision; (h) activatingsaid at least one vein-engaging element to said vein-engaging state; (i)manipulating said surgical instrument; and (j) removing said surgicalinstrument, thereby treating at least one of the at least onesuperficial varicose vein in the body region.
 9. The method according toclaim 1, wherein said surgical instrument has a pointed tip configuredto be inserted through the incision into a tissue in the body region.10. The method according to claim 9, wherein said at least onevein-engaging element is configured to be long enough to penetrate thewall of the at least one vein.
 11. The method according to claim 9,wherein said pointed tip is located at an end of said housing, said tipbeing designed for creating an incision through a skin layer andallowing introduction of said surgical instrument into said incisionthrough said skin layer.
 12. The method according to claim 1, whereinsaid at least one vein-engaging element comprises a plurality ofvein-engaging elements disposed substantially along the entire length ofsaid housing.
 13. The method according to claim 1, wherein said surgicalinstrument comprises a substantially tapered tip located at an end ofsaid housing, said tip being designed for allowing introduction of saidsurgical instrument into the incision through the skin layer.
 14. Themethod according to claim 1, wherein said at least one vein-engagingelement comprises at least one plurality of vein-engaging elements andat least two of said at least one plurality of vein-engaging elementsare substantially rigidly coupled to one another.
 15. The methodaccording to claim 1, wherein said at least one vein-engaging elementincludes a plurality of vein-engaging elements longitudinally spacedalong said housing.
 16. The method according to claim 1, wherein saidsurgical instrument includes a proximal end and each of said pluralityof vein-engaging elements includes a relatively wide base adjacent saidhousing, a sharp point at the outer edge, and a sloping portion betweensaid base and said outer edge, said sloping portion sloping towards saidproximal end of said surgical instrument.
 17. The method according toclaim 1, wherein said at least one vein-engaging element includes aplurality of vein-engaging elements; and wherein said engaging includessimultaneously engaging the outside of a plurality of veins with saidplurality of vein-engaging elements.
 18. The method according to claim17, wherein each of said plurality of veins is engaged by a separate oneof said plurality of vein-engaging elements.
 19. The method according toclaim 1, wherein said rotating includes hooking the at least one vein onsaid surgical instrument.
 20. The method according to claim 1, whereinthe at least one superficial varicose vein comprises a plurality ofsuperficial, axially spaced-apart veins.
 21. The method according toclaim 1, wherein said removing said surgical instrument includes atleast one of: puncturing a wall of the at least one vein; removing awall of the at least one vein; tearing a wall of the at least one vein;removing at least a portion of the at least one vein through saidincision; and hooking onto or passing through at least one additionalvein or vein knot.